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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL C-QUR MESH MESH, SURGICAL, POLYMERIC

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ATRIUM MEDICAL C-QUR MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); Obstruction/Occlusion (2422); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
A complete investigation was not able to be performed as no product number, lot number or sample was provided. Per the article adhesion characteristics of mesh placed intra peritoneally and adhesiolysis related complications during laparoscopic re-exploration after ventral hernia repair are associated with unique properties of the mesh and/or barrier. (b)(4).
 
Event Description
Received an article titled "prospective evaluation of adhesion characteristics to intra-peritoneal mesh and adhesiolysis related complications during laparoscopic re-exploration after prior ventral hernia repair". The article characterized the adhesion characteristics of absorbable and non-absorbable barrier coated meshes and to report adhesiolysis related complications during laparoscopic re-exploration after prior ventral hernia repair. Per the article adverse events included adhesions, infection, recurrence, small bowel obstruction, pain, incarceration and small bowel enterotomy.
 
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Brand NameC-QUR MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ATRIUM MEDICAL
40 continental blvd
merrimack NH 03054
Manufacturer (Section G)
ATRIUM MEDICAL
40 continental blvd
merrimack NH 03054
Manufacturer Contact
40 continental blvd
merrimack, NH 03054
MDR Report Key7455763
MDR Text Key106343454
Report Number3011175548-2018-00389
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K050311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 04/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/02/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/24/2018 Patient Sequence Number: 1
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